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ACTIVE NOT RECRUITING
NCT06445023
PHASE3

A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria

Sponsor: Celldex Therapeutics

View on ClinicalTrials.gov

Summary

The purpose of this study is to establish the efficacy, safety and tolerability of barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) inadequately controlled by non-sedating second generation H1-antihistamines in comparison to placebo.

Official title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab in Patients With Chronic Spontaneous Urticaria Who Remain Symptomatic Despite H1 Antihistamine Treatment (EMBARQ-CSU1)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

963

Start Date

2024-07-11

Completion Date

2027-04

Last Updated

2026-03-25

Healthy Volunteers

No

Interventions

BIOLOGICAL

barzolvolimab

Subcutaneous Administration

BIOLOGICAL

Matching placebo

Matching placebo Subcutaneous Administration

Locations (235)

Cahaba Dermatology Skin Health Center

Birmingham, Alabama, United States

First OC Dermatology - Fountain Valley

Fountain Valley, California, United States

310 Clinical Research

Inglewood, California, United States

Dermatology Research Associates

Los Angeles, California, United States

Focus Clinical Research - Los Angeles

Los Angeles, California, United States

Cura Clinical Research

Oxnard, California, United States

Allergy and Asthma Consultants

Redwood City, California, United States

Acclaim Clinical Research

San Diego, California, United States

West Dermatology Research Center

San Diego, California, United States

Therapeutics Clinical Research

San Diego, California, United States

Orso Health, Inc.

Torrance, California, United States

Integrated Research of Inland, Inc.

Upland, California, United States

Western States Clinical Research Inc

Wheat Ridge, Colorado, United States

Encore Medical Research Boynton Beach

Boynton Beach, Florida, United States

Direct Helpers Research Center

Hialeah, Florida, United States

GSI Clinical Research

Margate, Florida, United States

International Dermatology Research Inc - Miami

Miami, Florida, United States

Miami Dade Medical Research Institute, LLC

Miami, Florida, United States

Sarasota Clinical Research

Sarasota, Florida, United States

GCP Global Clinical Professionals, LLC

St. Petersburg, Florida, United States

Paradigm Clinical Research Boise

Boise, Idaho, United States

Endeavor Health

Skokie, Illinois, United States

Dawes Fretzin Clinical Research Group-7910 N Shadeland Ave

Indianapolis, Indiana, United States

DS Research of Kentucky, LLC

Louisville, Kentucky, United States

Allergy and Asthma Specialists PSC

Owensboro, Kentucky, United States

Clinical Trials Management LLC - Southshore Office

Metairie, Louisiana, United States

Johns Hopkins Asthma and Allergy Center

Baltimore, Maryland, United States

DermAssociates, LLC

Rockville, Maryland, United States

Institute For Asthma and Allergy

Wheaton, Maryland, United States

David Fivenson MD Dermatolgy PLLC

Ann Arbor, Michigan, United States

Resp Medicine Research Institute of MI

Ypsilanti, Michigan, United States

Dermatolgy and Skin Cancer Center

Lee's Summit, Missouri, United States

MediSearch, LLC

Saint Joseph, Missouri, United States

Montana Medical Research

Missoula, Montana, United States

Excel Clinical Research - Las Vegas

Las Vegas, Nevada, United States

Allergy Partners of N.J., P.C.

Ocean City, New Jersey, United States

Finger Lakes Medical Research, PLLC

Cortland, New York, United States

Sadick Research Group

New York, New York, United States

Bexley Dermatology Research

Bexley, Ohio, United States

Apex Clinical Research

Canton, Ohio, United States

Bernstein Clinical Research Center, LLC

Cincinnati, Ohio, United States

Wright State Physicians

Fairborn, Ohio, United States

Auni Allergy

Findlay, Ohio, United States

Apex Clinical Research Center

Mayfield Heights, Ohio, United States

Toledo Institute of Clinical Research

Toledo, Ohio, United States

Allergy Asthma and Clinical Research Center

Oklahoma City, Oklahoma, United States

Portland Allergy and Asthma

Clackamas, Oregon, United States

Oregon Medical Research Center

Portland, Oregon, United States

Clinical Research Philadelphia, LLC

Philadelphia, Pennsylvania, United States

National Allergy and Asthma Research, LLC - CRN - PPDS

North Charleston, South Carolina, United States

Alina Clinical Trials

Dallas, Texas, United States

Zenos Clinical Research

Dallas, Texas, United States

Epic Clinical Research

Lewisville, Texas, United States

VAST Clinical Research - Plano

Plano, Texas, United States

STAAMP Research, LLC - CRN

San Antonio, Texas, United States

Allergy and Asthma Care of Waco

Waco, Texas, United States

University of Utah - MidValley Dermatology - PPDS

Murray, Utah, United States

Premier Clinical Research

Spokane, Washington, United States

Buenos Aires Skin

Buenos Aires, Buenos Aires, Argentina

Fundacion Cidea

Buenos Aires, Buenos Aires, Argentina

CEMLO:Centro de Especialidades Medicas Lobos

Lobos, Buenos Aires, Argentina

Hospital Italiano De Buenos Aires

Buenos Aires, Buenos Aires F.D., Argentina

Conexa Investigacion Clinica

CABA, Buenos Aires F.D., Argentina

Aprillus Asistencia e Investigacion

CABA, Buenos Aires F.D., Argentina

CARE- Centro de Alergia y Enfermedades Respiratorias

CABA, Buenos Aires F.D., Argentina

Centro Respiratorio Infantil

Rosario, Sante Fe, Argentina

Instituto de Especialidades de Salud Rosario

Rosario, Sante Fe, Argentina

Servicio de Investigacion de Patologias Alergicas

Rosario, Sante Fe, Argentina

Instituto Medico de la Fundacion Estudios Clinicos

Rosario, Sante Fe, Argentina

C.I.C.E 9 de Julio - Sanatorio 9 de Julio S.A.

San Miguel de Tucumán, Tucumán Province, Argentina

Clinica Mayo

San Miguel de Tucumán, Tucumán Province, Argentina

Centro de Investigaciones Medicas Tucuman

San Miguel de Tucumán, Tucumán Province, Argentina

Centro Médico Vitae

Buenos Aires, Argentina

Instituto de Alergia e Inmunologia del Sur

Buenos Aires, Argentina

UZ Antwerp

Edegem, Antwerpen, Belgium

UZ Leuven

Leuven, Vlaams Brabant, Belgium

UZ Brussel

Brussels, Belgium

Saint Luc

Brussels, Belgium

CHU de Liège

Brussels, Belgium

Hôpital Erasme - Erasme Medical Center - PPDS

Brussels, Belgium

UZ Gent

Ghent, Belgium

Dermatologie Maldegem

Maldegem, Belgium

AlergoAlpha Allergia e Immunologia

Barueri, Brazil

Instituto de Pesquisas Clínicas LTDA Brasilia

Brasília, Brazil

Fundação Universidade de Caxias do Sul - Instituto de Pesquisas em Saúde

Caxias do Sul, Brazil

Centro Paraibano de Pesquisas e Estudos Clínicos

João Pessoa, Brazil

Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)

Porto Alegre, Brazil

Hospital Universitário Clementino Fraga Filho (UFRJ)

Rio de Janeiro, Brazil

Clinica IBIS

Salvador, Brazil

Centro de Estudos de Pneumologia da Faculdade de Medecina do ABC

Santo André, Brazil

Centro de Pesquisa SVRI Hospital e Maternidade Christóvão da Gama

Santo André, Brazil

Clínica de Alergia Martti Antila

São Paulo, Brazil

Vidamed Care Clínica E Residência

Vitória, Brazil

"Medical center MedTech Services" OOD

Haskovo, Bulgaria

Diagnostic Consultative Center Pulmed

Plovdiv, Bulgaria

Aipsimpa D-R Talyat Sali Cholak Eood

Razgrad, Bulgaria

Medical Center Iskar EOOD

Sofia, Bulgaria

MC Excelsior OOD

Sofia, Bulgaria

DCC Fokus - 5 OOD LZIBP

Sofia, Bulgaria

Medical Center Hera EOOD

Sofia, Bulgaria

UMHATEM " N.I.Pirogov"

Sofia, Bulgaria

Medical Center Pulmovision

Sofia, Bulgaria

MBAL Sv. Panteleymon AD

Yambol, Bulgaria

Alberta DermaSurgery Centre - Probity - PPDS

Edmonton, Alberta, Canada

Skincare Research

St. John's, Newfoundland and Labrador, Canada

Triple A Lab

Hamilton, Ontario, Canada

Lynderm Research Inc

Markham, Ontario, Canada

Centre for Dermatology and Cosmetic Surgery

Richmond Hill, Ontario, Canada

Canadian Dermatology Centre - Probity - PPDS

Toronto, Ontario, Canada

Evidence Based Medical Educator Inc.

Toronto, Ontario, Canada

Rejuvenation Dermatology and Aesthetics

Calgary, Canada

Fakultní nemocnice Královské Vinohrady, Dermatovenerologická klinika

Prague, Czechia

Sanatorium profesora Arenbergera

Prague, Czechia

Kožní ambulance Fialová, s.r.o.

Prague, Czechia

Fakultní nemocnice Bulovka, Dermatovenerologická klinika

Prague, Czechia

Aarhus Universitetshospital

Aarhus N, Denmark

Bispebjerg Hospital

Copenhagen NV, Denmark

Gentofte Hospital

Hellerup, Denmark

Hospices Civils de Lyon - Hôpital Lyon Sud

Pierre-Bénite, Rhone, France

CHU de Grenoble Alpes - Hôpital Michallon

La Tronche, France

Cabinet du Dr Ruer-Mulard Mireille

Martigues, France

CHRU Nantes Hôtel Dieu

Nantes, France

CHU de Nice-Hôpital L'Archet

Nice, France

Hôpital La Pitié Salpêtrière

Paris, France

CHRU Rouen - Hôpital Charles-Nicolle

Rouen, France

Praxis Dr. Beate Schwarz

Langenau, Baden-Wurttemberg, Germany

Rosenpark Research GmbH

Darmstadt, Hesse, Germany

Siteworks Prüfzentrum Lohne - PPDS

Löhne, Lower Saxony, Germany

ProDerma

Dülmen, North Rhine-Westphalia, Germany

UKSH Kiel

Kiel, Schleswig-Holstein, Germany

Medizinisches Versorgungszentrum DermaKiel GmbH

Kiel, Schleswig-Holstein, Germany

Fraunhofer-Institut für Translationale Medizin und Pharmakologie ITMP - Berlin

Berlin, Germany

Studienzentrum an der Hase Weyergraf / Frick / Heiber GbR

Bramsche, Germany

Dermatologie Quist

Mainz, Germany

LMU Klinikum der Universität München

München, Germany

Naval Hospital of Athens

Athens, Greece

Andreas Syggros Hospital

Athens, Greece

Attikon General University Hospital

Attiki, Greece

General Hospital of Thessaloniki 'Papageorgiou'

Thessaloniki, Greece

Azienda Ospedaliero Universitaria delle Marche

Ancona, Italy

ASST Carlo Poma

Mantua, Italy

Istituti Clinici Scientifici Maugeri IRCCS

Milan, Italy

Azienda Ospedaliera Universitaria Federico II

Naples, Italy

Azienda Ospedaliera Ordine Mauriziano di Torino

Torino, Italy

Centro Ricerche Cliniche Verona s.r.l./Ospedale G.B. Rossi Borgo Roma

Verona, Italy

Hospital Pulau Pinang

George Town, Malaysia

Hospital Raja Permaisuri Bainun

Ipoh, Malaysia

Hospital Sultan Ismail

Johor Bahru, Malaysia

Hospital Kuala Lumpur

Kuala Lumpur, Malaysia

Hospital Umum Sarawak

Kuching, Malaysia

Clinica Internacional - Sede Lima

Lima, Peru

Clinica Ricardo Palma

Lima, Peru

Clinica San Felipe

Lima, Peru

Medic Ser S.A.C. Auna Clinica Delgado

Lima, Peru

NZOZ Specjalistyczny Ośrodek Dermatologiczny "DERMAL"

Bialystok, Poland

Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny Anna Ploszczuk

Bialystok, Poland

Pratia Bydgoszcz

Bydgoszcz, Poland

Ambulatorium Sp. zo.o.

Elblag, Poland

Centrum Badan Klinicznych PI-House Sp. z o.o

Gdansk, Poland

"SYNEXUS POLSKA" sp. z o.o. Odział w Katowicach

Katowice, Poland

Centrum Medyczne Katowice - PRATIA - PPDS

Katowice, Poland

Polimedica PTG Kielce

Kielce, Poland

Centrum Nowoczesnych Terapii "Dobry Lekarz" Sp. o.o.

Krakow, Poland

Santa Familia PTG Łódź

Lodz, Poland

Oddzial Kliniczny Chorob Wewnetrznych, Astmy i Alergii z Odcinkiem dla Dzieci, Uniwesytecki Szpital Kliniczny nr 1 im. N. Barlickiego w Lodzi

Lodz, Poland

Pratia S.A. Centrum Medyczne Pratia Poznań

Poznan, Poland

Specjalistyczna Przychodnai Lekarska Alergo-Med Sp. z o.o.

Poznan, Poland

Synexus Polska Sp. z o.o. - Poznaniu

Poznan, Poland

NSZOZ Puls-Med Anna Bogusz, Agnieszka Musielak spolka jawna

Skarżysko-Kamienna, Poland

Laser Clinic S.C

Szczecin, Poland

MICS Centrum Medyczne Torun

Torun, Poland

Klinika Ambroziak Dermatologia

Warsaw, Poland

Royalderm Agnieszka Nawrocka

Warsaw, Poland

FutureMeds - Targowek - PPDS

Warsaw, Poland

Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Dr hab. Med. Eleonory Reicher

Warsaw, Poland

Ginemedica

Wroclaw, Poland

Diagnostic Consultative Center Pulmed

Wroclaw, Poland

Przychodnia FutureMeds Wroclaw

Wroclaw, Poland

EuroMediCare Szpital Specjalistyczny z Przychodnia we Wroclawiu

Wroclaw, Poland

Slaski Park Technologii Medycznych Kardio-Med Silesia Sp. z o. o.

Zabrze, Poland

ULS da Região de Aveiro, EPE - Hospital Infante D. Pedro

Aveiro, Portugal

Centro Clínico Académico, Braga - Hospital de Braga

Braga, Portugal

ULS de Coimbra, EPE - Hospitais da Universidade de Coimbra

Coimbra, Portugal

Hospital Lusiadas Lisboa

Lisbon, Portugal

Unidade Local de Saúde de Santa Maria

Lisbon, Portugal

ULS de Matosinhos, EPE - Hospital Pedro Hispano

Matosinhos Municipality, Portugal

ULS de Santo António, EPE - Hospital de Santo António

Porto, Portugal

ULS da Arrábida, EPE - Hospital de São Bernardo

Setúbal, Portugal

Unidade Local de Saúde de Gaia/Espinho - Unidade I

Vila Nova de Gaia, Portugal

Iatros International

Bloemfontein, Free State, South Africa

Worthwhile Clinical Trials

Benoni, Gauteng, South Africa

Ubuntu Clinical Research

Krugersdorp, Gauteng, South Africa

Newtown Clinical Research Centre

Newtown, Gauteng, South Africa

About Allergy

Pretoria, Gauteng, South Africa

FCRN Clinical Trial Centre

Vereeniging, Gauteng, South Africa

Synapta Clinical Research

Durban, KwaZulu-Natal, South Africa

University of Cape Town Lung Institute

Mowbray, Western Cape, South Africa

Infinity Dermatology Inc

Durban, South Africa

Meditrial

Pietermaritzburg, South Africa

Global Clinical Trials

Pretoria, South Africa

Sandton Medical Research Centre

Sandton, South Africa

Allergy and Asthma Centre

Westville, South Africa

Hanyang University Seoul Hospital

Seongdong, Seoul Teugbyesolsi, South Korea

Korea University Ansan Hospital

Ansan, South Korea

CHA Bundang Medical Center, CHA University

Seongnam-si, South Korea

Seoul National University Bundang Hospital

Seongnam-si, South Korea

Seoul National University Hospital

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Ajou University Hospital

Suwon, South Korea

Corporació Sanitaria Parc Taulí

Sabadell, Barcelona, Spain

Hospital General Universitario Dr. Balmis

Alicante, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Hospital Universitari de Bellvitge

Barcelona, Spain

C.H. Regional Reina Sofia

Córdoba, Spain

Future Meds Madrid

Madrid, Spain

Hospital Clínico San Carlos

Madrid, Spain

Complejo Asistencial Universitario De Salamanca

Salamanca, Spain

Hospital Universitario de la Plana

Villarreal de Huerva, Spain

National Taiwan University Hospital Hsin-Chu Branch

Hsinchu, Taiwan

Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan

China Medical University Hospital -PPDS

Taichung, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

MacKay Memorial Hospital -Taipei branch

Taipei, Taiwan

Chang Gung Memorial Hospital, Linkou

Taoyuan District, Taiwan

Ankara Universitesi Tip Fakultesi Hastaneleri - Cebeci Hastanesi

Ankara, Turkey (Türkiye)

Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi

Ankara, Turkey (Türkiye)

Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi

Fatih, Turkey (Türkiye)

Kocaeli Universitesi Tip Fakultesi Hastanesi

Kocaeli, Turkey (Türkiye)

Erciyes University School of Medicine

Melikgazi, Turkey (Türkiye)

Ondokuz Mayis University Hospital

Samsun, Turkey (Türkiye)

Karadeniz Teknik Universitesi Tip Fakultesi Hastanesi

Trabzon, Turkey (Türkiye)